Notice names this product. Biomerieux’s VITEK 2 AST-N447 TEST KIT Product reference 424620 is named in FDA Class II recall Z-2715-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. Identifying details: Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.. Units affected: 45,900 cards. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
VITEK 2 AST-N447 TEST KIT Product reference 424620
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Company / brand: Biomerieux recalls
Affected product: VITEK 2 AST-N447 TEST KIT Product reference 424620 recall status
Official ID Z-2715-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.